Austin Retina Associates
Clinical Research Coordinator I
Position Summary Our goal is to advance retinal research, offer new treatment opportunities to our community, and provide the highest quality patient care. Austin Retina Associates is seeking a responsible, self motivated, individual to provide research coordination in a thriving retina practice’s growing research department. Our ideal candidate is passionate about patient care and the administrative aspects of clinical research.
Duties/Responsibilities
Performs required trainings and obtains applicable certifications necessary to participate in specific study protocols including GCP, IATA, and other protocol-specific training
Facilitates and coordinates daily clinical trial activities
Primary coordinator on 1+single site studies within the practice
Ensure study staff are trained on study protocols, ICF, manuals and document all trainings
Will create, manage and maintain source documents for each assigned trial
Attend teleconferences and meetings as requested by research manager
Review and understand all study protocols including proceedings, timeline, inclusion/exclusion criteria, confidentiality and privacy protections
Provide care for study patients during visits, perform diagnostic testing,
schedule appointments and educate patients regarding retinal condition, available treatment
options and details of study protocol
Preview with patient the involvement of potential study and complete both physician and patient consent
Provide ongoing communication regarding study to patient’s physicians
Perform data entry in multiple Electronic Data Capture, EDC, systems
Primary contact for monitor site visits, preparing documentation, and making corrections to meet requirements and deadlines as needed
Communicate and coordinate with study sponsor, monitors, and CRO’s including data entry queries, audits and monitoring visits
Performs multiple imaging procedures required for specific study protocols; to be certified in digital imaging reading centers as utilized by each study sponsor
Manages and maintains all regulatory information about the study including protocols, investigator brochure, IRB documents, Investigator disclosures, CVs, training, documentation, instructions and reporting requirements for the IRB and the sponsor
Collects updated medical history, ALL adverse and serious adverse events and reports to the sponsor and IRB within the required timeframes
Screens patients for eligibility using protocol-specific inclusion and exclusion criteria,
documenting each potential participant's eligibility accurately
Other duties assigned on an as needed basis delegated by study protocol or manager
Required Attributes
Perform multiple imaging procedures required for each specific study protocol with the intent to be certified through the digital imaging reading center utilized by each study sponsor
Train and certify to perform refraction and vision testing
Deliver safe and appropriate care to patients in addition to the requirements outlined in Study protocol, Good Clinical Practice (GCP) Guidelines, and Standard Operating Procedures (SOPs)
Ability and willingness to perform venipunctures and process samples with training provided
Master multiple computer systems including Google, MicrosoftOffice, Teams, data management
Ability to develop and maintain strong relationships with physicians, coworkers, and patients
Will master ophthalmology and retina terminology
ICH GCP Training/Certification
Certified Ophthalmic Assistant
Cooperates with supervisory staff, physicians, peers, external customers, and patients in a positive, energetic, and professional manner
Preferred Attributes
Demonstrated effectiveness showing courtesy, diligence, integrity, and teamwork in alignment with ARA core values
Excellent organizational and time management skills ensuring all tasks are completed in a timely manner satisfactory to the organization with ability to independently manage workflow
Strong interpersonal skills including effective listening, clear communication, effective customer problem resolution with warm encouraging demeanor
Bilingual in Spanish
Ophthalmic experience
Demonstrates high-level initiative and critical thinking skills
College degree preferred, significant relevant experience, and/or Ophthalmic experience
CRA tier III and/or 18 months with prior performance review or assessment exceeding expectations
Experience in the following is preferred but not required: FA, FP, FAF, and IR imaging on
OIS/Topcon, Heidelberg and Optos, SD-OCT scanning on Heidelberg and Cirrus systems
CCRP or CCRC Certification
Experience with Real Time CTMS
Position Details
Schedule approximately 8-5pm during weekdays
Hourly pay, FLSA non-exempt, eligible for overtime
Physical Demands and Requirements
Prolonged standing and walking, some sitting, talking and hearing both in person and by telephone; use hands to finger, handle and feel objects or controls; reach with hands and arms. Regularly required to stoop, kneel, bend, crouch and lift up to 40 pounds on occasion. Specific vision abilities required by this job includes viewing multiple computer screens, close vision, distance vision, depth perception, color vision and the ability to adjust focus. Viewing images and operating computer devices constantly.
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Position Summary Our goal is to advance retinal research, offer new treatment opportunities to our community, and provide the highest quality patient care. Austin Retina Associates is seeking a responsible, self motivated, individual to provide research coordination in a thriving retina practice’s growing research department. Our ideal candidate is passionate about patient care and the administrative aspects of clinical research.
Duties/Responsibilities
Performs required trainings and obtains applicable certifications necessary to participate in specific study protocols including GCP, IATA, and other protocol-specific training
Facilitates and coordinates daily clinical trial activities
Primary coordinator on 1+single site studies within the practice
Ensure study staff are trained on study protocols, ICF, manuals and document all trainings
Will create, manage and maintain source documents for each assigned trial
Attend teleconferences and meetings as requested by research manager
Review and understand all study protocols including proceedings, timeline, inclusion/exclusion criteria, confidentiality and privacy protections
Provide care for study patients during visits, perform diagnostic testing,
schedule appointments and educate patients regarding retinal condition, available treatment
options and details of study protocol
Preview with patient the involvement of potential study and complete both physician and patient consent
Provide ongoing communication regarding study to patient’s physicians
Perform data entry in multiple Electronic Data Capture, EDC, systems
Primary contact for monitor site visits, preparing documentation, and making corrections to meet requirements and deadlines as needed
Communicate and coordinate with study sponsor, monitors, and CRO’s including data entry queries, audits and monitoring visits
Performs multiple imaging procedures required for specific study protocols; to be certified in digital imaging reading centers as utilized by each study sponsor
Manages and maintains all regulatory information about the study including protocols, investigator brochure, IRB documents, Investigator disclosures, CVs, training, documentation, instructions and reporting requirements for the IRB and the sponsor
Collects updated medical history, ALL adverse and serious adverse events and reports to the sponsor and IRB within the required timeframes
Screens patients for eligibility using protocol-specific inclusion and exclusion criteria,
documenting each potential participant's eligibility accurately
Other duties assigned on an as needed basis delegated by study protocol or manager
Required Attributes
Perform multiple imaging procedures required for each specific study protocol with the intent to be certified through the digital imaging reading center utilized by each study sponsor
Train and certify to perform refraction and vision testing
Deliver safe and appropriate care to patients in addition to the requirements outlined in Study protocol, Good Clinical Practice (GCP) Guidelines, and Standard Operating Procedures (SOPs)
Ability and willingness to perform venipunctures and process samples with training provided
Master multiple computer systems including Google, MicrosoftOffice, Teams, data management
Ability to develop and maintain strong relationships with physicians, coworkers, and patients
Will master ophthalmology and retina terminology
ICH GCP Training/Certification
Certified Ophthalmic Assistant
Cooperates with supervisory staff, physicians, peers, external customers, and patients in a positive, energetic, and professional manner
Preferred Attributes
Demonstrated effectiveness showing courtesy, diligence, integrity, and teamwork in alignment with ARA core values
Excellent organizational and time management skills ensuring all tasks are completed in a timely manner satisfactory to the organization with ability to independently manage workflow
Strong interpersonal skills including effective listening, clear communication, effective customer problem resolution with warm encouraging demeanor
Bilingual in Spanish
Ophthalmic experience
Demonstrates high-level initiative and critical thinking skills
College degree preferred, significant relevant experience, and/or Ophthalmic experience
CRA tier III and/or 18 months with prior performance review or assessment exceeding expectations
Experience in the following is preferred but not required: FA, FP, FAF, and IR imaging on
OIS/Topcon, Heidelberg and Optos, SD-OCT scanning on Heidelberg and Cirrus systems
CCRP or CCRC Certification
Experience with Real Time CTMS
Position Details
Schedule approximately 8-5pm during weekdays
Hourly pay, FLSA non-exempt, eligible for overtime
Physical Demands and Requirements
Prolonged standing and walking, some sitting, talking and hearing both in person and by telephone; use hands to finger, handle and feel objects or controls; reach with hands and arms. Regularly required to stoop, kneel, bend, crouch and lift up to 40 pounds on occasion. Specific vision abilities required by this job includes viewing multiple computer screens, close vision, distance vision, depth perception, color vision and the ability to adjust focus. Viewing images and operating computer devices constantly.
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